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COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.

COLLOSS E is a bone void filler extracted from the extracellular n diaphyseal equine bone. It is a lyophilizate in collagenous matrix form, consisting of collagen Type I chains with other insoluble proteins present.

COLLOSS E is dry with a cotton-like appearance, having a white to slightly yellowish color. The product is processed under aseptic conditions and is nonpyrogenic. It is supplied in a 20 mg quantity, packaged in a vial inside of a Tyvek pouch. The inner surfaces of the pouch are terminally sterilized by plasma sterilization.

I am sorry, but the provided text does not contain information regarding acceptance criteria, reported device performance, or any study details that demonstrate the device meets acceptance criteria. The document is a 510(k) summary for a bone void filler called COLLOSS™ E, focusing on administrative information, device description, intended use, technological characteristics, and substantial equivalence to predicate devices. It explicitly states: "No performance standards have been established for this type of device." and briefly mentions "The results of animal testing demonstrated that COLLOSS E is suitable for use as a bone void filler." but does not provide any specifics about this testing.

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